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Activity Details

135 Mon, 8/9/2021, 1:30 PM - 3:20 PM Virtual
Multiplicity, Missing Data and Other Topics — Contributed Speed
Biopharmaceutical Section
Chair(s): Madhurima Majumder, Bayer
1:35 PM On Assessing Effectiveness of New Assets Using Historical Response Data: A Bayesian Approach
Chunsheng He, BMS; Yike Tang, UIC; Shu-Pang Huang, BMS
1:40 PM Evidence Synthesis of Randomized and Nonrandomized Studies for Decision-Making
Hongwei Wang, AbbVie; Weili He, AbbVie; Tianming Gao, AbbVie; Linyu Shi, AbbVie
1:45 PM Indirect Treatment Comparison with Evidences of Different Sources and Quality
Tianming Gao, AbbVie; Hongwei Wang, AbbVie; Weili He, AbbVie; Linyu Shi, AbbVie
1:50 PM Continuous Learning from Small Efficacy Studies in Drug Development
Haiyuan Zhu, Sunovion Pharmaceuticals; Robert Hayes, Sunovion Pharmaceuticals
1:55 PM Simulating Clinical Trials Data with Synthetic.Cdisc.Data and Respectables
Gabriel Becker, Clindata Insights; Adrian Waddell, F. Hoffmann-La Roche
2:00 PM Expedite Rare Disease Drug Development Through Bayesian Analyses, External Controls, and Real-World Data
Florence Yong, Pfizer Inc.; Jeffrey Palmer, Pfizer Inc
2:05 PM A Novel Approach to Augment Single-Arm Clinical Studies with Real-World Data
Archie Sachdeva, University of Florida; Ram Tiwari, Bristol Myers Squibb; Subharup Guha, University of Florida
2:10 PM Treatment Effects Across Subgroups Based on Shrinkage Estimation
Amarjot Kaur, Merck & Co., Inc.; qing li, Merck & co., Inc.; Jia Hua, Merck
2:15 PM Exploring the Impact of Different Endpoint Definitions for MMRM and Related Missing Data Problems
Yaoyuan Vincent Tan, Vertex Pharmaceuticals; Fengjuan Xuan, Vertex Pharmaceuticals
2:20 PM A Novel Return-to-Baseline Imputation Method for Missing Data in Clinical Trials
Biyue Dai, Eli Lilly and Company; Yongming Qu, Eli Lilly and Company
2:30 PM Analysis of Crossover Designs for Longitudinal Binary Data with Ignorable and Nonignorable Dropout
Xi Wang, Pennsylvania State University College of Medicine; Vernon M. Chinchilli, Pennsylvania State University College of Medicine
2:35 PM Simulating Treatment Discontinuation in Clinical Trials
Ahmad Hakeem Abdul Wahab, Purdue University, Department of Statistics; Hege Michiels, Department of Applied Mathematics, Computer Science and Statistics, Ghent University; Arman Sabbaghi, Purdue University, Department of Statistics; Stephen J Ruberg, Analytix Thinking, LLC
2:40 PM A Bias Correction Method for Hazard Ratio Estimation and Its Inference in a Multiple-Arm Clinical Trial
Liji Shen, Merck & Co. Inc; Ziwen Wei, Merck & Co. Inc; Xuan Deng, Merck & Co. Inc
2:45 PM Treatment Effect Bias from Sample Snooping: Blinding Outcomes Is Neither Necessary nor Sufficient
Aaron Fisher, Foundation Medicine Inc
2:50 PM On Weighted Holm Procedures
Beibei Li, New Jersey Institute of Technology; Wenge Guo, New Jersey Institute of Technology
2:55 PM Statistical Methods to Assess In-Vitro Comparability
Michael Daniel Cid Lucagbo, University of Maryland, Baltimore County and University of the Philippines Diliman; Tianjiao Dai, U.S. Food and Drug Administration; Yixin Ren, Merck & Co., Inc.; Meiyu Shen, Office of Biostatistics CDER, FDA; Yi Tsong, CDER, US FDA
3:00 PM Floor Discussion